New Publications Confirm Clinical And Scientific Benefits Of Symbicort Smart, A New Approach To Manage Asthma

Main Category: Respiratory / Asthma
Article Date: 19 Apr 2007 - 6:00 PDT

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New data published in the International Journal of Clinical Practice show that Symbicort® Maintenance And Reliever Therapy (Symbicort SMART®) delivers greater overall asthma control (based on exacerbation prevention and daily symptoms) compared with a traditional approach with higher fixed maintenance doses of either budesonide/formoterol (Symbicort) or salmeterol/fluticasone (SeretideTM), plus short-acting reliever medication. These data, from the COMPASS trial, show that asthma patients using Symbicort SMART demonstrated a 39% reduction in severe asthma exacerbations - including a 39% reduction in the requirement for emergency room treatment and / or hospital admissions - compared to patients treated with a traditional approach of fixed dose SeretideTM and short-acting bronchodilator (SABA) as reliever.

The publication of the COMPASS study is complemented by the recent publication of a scientific review in the European Respiratory Journal2, which provides a scientific rationale for using Symbicort as both maintenance and reliever therapy and advocates this as the potential mainstay of future asthma treatment.

Symbicort SMART is a new approach to asthma management, and the first to provide patients with both maintenance and reliever therapy together in one inhaler. With Symbicort SMART, patients receive a daily maintenance treatment in line with normal practice to establish asthma control, and can then take additional inhalations 'as needed' if symptoms occur, to provide both rapid symptom relief and an immediate increase in anti-inflammatory therapy. Treating the underlying inflammation with every inhalation leads to greater long term asthma control.

"COMPASS was an important study to undertake, since treatment guidelines issued by the Global Initiative for Asthma (GINA) show that reducing the incidence of exacerbations is by far the most important measure of asthma control," commented Professor Piotr Kuna, lead investigator of COMPASS. "The Symbicort SMART approach provides increased efficacy in controlling exacerbations with greater simplicity and offers a significant improvement over conventional fixed dose ICS / LABA treatment."

COMPASS1, a six-month double-blind study conducted in 3,335 patients, is the largest study of its type in asthma. It provides clear clinical evidence that treatment with Symbicort SMART offers a significant improvement in efficacy over fixed, twice-daily combinations of higher-dose inhaled corticosteroid (ICS)/ long-acting bronchodilator (LABA) and reliever, using two inhalers, in the management of moderate and severe persistent asthma, and achieves this with a lower maintenance dose. Overall, patients in the Symbicort SMART groups demonstrated a 25% reduction in mean ICS levels compared with either comparator group when assessed using standard dose equivalents (beclomethasone dipropionate equivalents).

The scientific review in the ERJ highlights that Symbicort SMART is the only ICS/LABA combination available with proven efficacy when used as a single inhaler for both maintenance and reliever therapy. This single inhaler approach is only possible with Symbicort due to its two components which have potentially synergistic effects: budesonide, an ICS to provide an anti-inflammatory effect in the airways within hours, and the LABA, formoterol. Formoterol is a unique bronchodilator that is rapid in effect, unlike salmeterol, and long lasting. Salmeterol does not have the properties that enable it to be used in this way and consequently, Seretide (salmeterol/fluticasone) cannot be used as a single inhaler approach for both maintenance and relief.

The author of the review, Professor Barnes, comments; "Conventional management of asthma involves use of separate medication inhalers for maintenance treatment and relief of asthma exacerbations. This can lead to poor compliance and symptom control. The single inhaler approach to therapy with Symbicort SMART, where maintenance and relief is provided in a single inhaler, is very effective, simple and cost effective. The results of the COMPASS study provide added evidence of the value of the Symbicort SMART treatment approach in clinical practice."

These publications build on the evidence base demonstrating the benefits of Symbicort SMART as a highly effective and simpler approach for asthma management, and support recently revised international treatment guidelines on best practice in the prevention and treatment of asthma issued by GINA, the Global Initiative for Asthma. These guidelines highlight the need for a new management approach and support the use of combination inhalers containing formoterol and budesonide for both maintenance and reliever therapy.3

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index. www.astrazeneca.com

References

1. P. Kuna, M. J. Peters, A. I. Manjra, C. Jorup, I. P. Naya, N. E. Martínez-Jimenez, R. Buhl. Effect of budesonide/formoterol maintenance and reliever therapy on asthma exacerbations. Int J Clin Pract. May 2007 Vol. 61 Issue 5 Page 725-736
2. Barnes PJ: Scientific rationale for using a single inhaler for asthma control Eur Respir J 2007; 29:587-595
3. The Global Initiative for Asthma (GINA). GINA Report, Global Strategy for Asthma Management and Prevention, published November 2006. www.ginasthma.com

COMPASS

-- COMPASS1 compared Symbicort SMART 160/4.5 mcg bid (budesonide/formoterol used as both maintenance and reliever therapy) with a higher maintenance dose of budesonide/formoterol 320/9 mcg bid or salmeterol/fluticasone 250/50 mcg bid plus separate relief therapy with terbutaline, a short-acting beta agonist, in patients who were symptomatic on their current ICS treatment

Results showed that:

-- Symbicort SMART reduces asthma exacerbations and maintains symptom control at a reduced drug load compared with higher maintenance doses of budesonide/formoterol or salmeterol/fluticasone and SABA

-- Indicators of daily asthma control were similarly improved in all groups of patients

-- Symbicort SMART prolonged the time to first severe asthma exacerbation versus a higher fixed-dose budesonide/formoterol and salmeterol/fluticasone

-- Symbicort SMART was associated with 28% fewer exacerbations compared with a higher fixed-dose budesonide/formoterol and 39% compared with salmeterol/fluticasone (both p<0.01)

-- The mean exacerbation rate for each of the groups was 12, 16 and 19 per 100 patients per 6 months in the Symbicort SMART, budesonide/formoterol and salmeterol/fluticasone groups, respectively

-- Symbicort SMART-treated patients used ≈25% less ICS (beclomethasone equivalent) than patients in the fixed dose groups

-- All treatments were well-tolerated

Symbicort SMART

-- Patients prescribed Symbicort SMART take a maintenance dose of Symbicort every day in line with normal practice to establish asthma control and take additional inhalations 'as needed' of Symbicort if symptoms occur, to provide both rapid symptom relief and improved asthma control.

-- Symbicort SMART successfully completed the European Union Mutual Recognition Procedure (MRP) in October 2006 and it is currently approved in over 40 countries worldwide (outside US).

Symbicort

-- Symbicort is currently approved in more than 90 countries; sales were $585 million in the first half 2006 (up 24 percent on 2005 figures) and have now reached more than five million treatment years

-- Symbicort received FDA approval in the US in July 2006 for maintenance treatment of asthma (in patients from 12 years of age)

www.symbicort.com